Medical Devices LIMS

Medical device manufacturers rely on laboratory testing to ensure their products meet exacting manufacturing quality standards such as 21 CFR Part 820 and ISO 13485. This testing covers all aspects of the manufacturing process from raw material acceptance to environmental monitoring to biocompatibility. Whether these are the responsibilities of a single lab or multiple departments, all testing results must be accessible by stakeholders throughout the organization. These reasons and more make a flexible, scalable LIMS essential for any medical device testing laboratory.

LabLynx configures ELab LIMS for Medical Devices with everything your lab needs to support your company’s quality, safety and business goals. Our modular LIMS platform scales to meet the needs of testing operations at any scale. As the central source of truth for your lab’s testing activities, ELab LIMS improves data sharing within your lab and with the rest of the organization. At the same time, ELab LIMS for Medical Devices makes laboratory operations more efficient and better able to meet ISO 17025, ASCA and other laboratory standards.